ONC-392 and Pembrolizumab in Platinum Resistant Ovarian Cancer

Part of paid clinical trials in Goodyear, Arizona.

Sponsor
OncoC4, Inc.
Study ID
NCT05446298
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Fallopian Tube Cancer
  • High Grade Serous Adenocarcinoma of Ovary
  • Ovarian Cancer
  • Primary Peritoneal Carcinoma

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ONC-392 — DRUG
    ONC-392 will be given by IV infusion, q3w.
  • Pembrolizumab — DRUG
    Pembrolizumab in fixed dose of 200 mg will be given by IV infusion, q3w.

Study Details

This is a study to test the safety and efficacy with the combination of a next generation anti-CTLA-4 antibody, ONC-392, and anti-PD-1 antibody, pembrolizumab, in platinum resistant ovarian cancer patients.

Key Dates

First listed
Jul 6, 2022
Start date
Dec 22, 2022
Status verified
Apr 2026
Primary completion
Aug 30, 2026
Completion
Aug 30, 2026

Study Design

Enrollment
58 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1 mg/kg ONC-392 and 200 mg pembrolizumab
    Arm A: Pembrolizumab 200 mg will be administered by IV infusion over 30 minutes, followed by ONC-392 at 1.0 mg/kg will be administered by IV infusion over 60 minutes, q3w.
  • Experimental: 2 mg/kg ONC-392 and 200 mg pembrolizumab
    Arm B: Pembrolizumab 200 mg will be administered by IV infusion over 30 minutes, followed by ONC-392 at 2.0 mg/kg will be administered by IV infusion over 60 minutes, q3w.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: 24 months ]

Locations (21)

FacilityCityStateZIPSite coordinators
Cancer Treatment Centers of America, Phoenix. 403GoodyearArizona85338-
Honor Health, USOR, 406PhoenixArizona85082-
Nuvance Health System, 401DanburyConnecticut06856-
Baptist MD Anderson Cancer Center, 404JacksonvilleFlorida32207-
Sudarshan Sharma, MD. LTD. 414HinsdaleIllinois60521-
Cancer Treatment Centers of America, Chicago. 410ZionIllinois60099-
Northwest Cancer Centers - Dyer, IN - USOR, 422DyerIndiana46311-
Baptist Health Lexington, 407LexingtonKentucky40503-
Norton Cancer Institute - St. Matthews, 416LouisvilleKentucky40207-
Willis-Knighton Physician Network / Gynecologic Oncology Associates, 409ShreveportLouisiana71103-
Minnesota Oncology Hematology, P. A. - USOR, 421MaplewoodMinnesota55109-
Center of Hope, 413RenoNevada89511-
The Valley Hosptial, Inc. 411RidgewoodNew Jersey07450-
Women's Cancer Care Associates, LLC. 405AlbanyNew York12208-
The Ohio State University James Cancer Center, 412ColumbusOhio43210-
Oncology Associates of Oregon, P. C. - USOR. 419EugeneOregon97401-
Texas Oncology, P. A. - Austin, USOR. 417AustinTexas78731-
Texas Oncology, P.A., Fort Worth - USOR. 420Fort WorthTexas76104-
Texas Oncology, P. A. Woodlands - USOR, 418The WoodlandsTexas77380-
Texas Oncology - Northeast Texas - USOR, 423TylerTexas75702-
Medical College of Wisconsin, 408MilwaukeeWisconsin53226-

Find similar trials in Goodyear, AZ

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Cancer Treatment Centers of America, Phoenix. 403· Goodyear, AZHonor Health, USOR, 406· Phoenix, AZNuvance Health System, 401· Danbury, CTBaptist MD Anderson Cancer Center, 404· Jacksonville, FLSudarshan Sharma, MD. LTD. 414· Hinsdale, ILCancer Treatment Centers of America, Chicago. 410· Zion, IL

Related Studies